NDC 40076-953

ZOVIRAX

Acyclovir

ZOVIRAX is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Prestium Pharma, Inc.. The primary component is Acyclovir.

• Product ID: 40076-953_9e574cb0-de5c-47b0-91d3-044a7ad212d9
• NDC: 40076-953
• Product Type: Human Prescription Drug
• Proprietary Name: ZOVIRAX
• Generic Name: Acyclovir
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2014-02-07
• Marketing End Date: 2019-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA019909
• Labeler Name: Prestium Pharma, Inc.
• Substance Name: ACYCLOVIR
• Active Ingredient Strength: 200 mg/5mL
• Pharm Classes: DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]
• NDC Exclude Flag: N

Packaging

NDC 40076-953-96

473 mL in 1 BOTTLE (40076-953-96)

• Marketing Start Date: 2014-02-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40076-953-96 [40076095396]

ZOVIRAX SUSPENSION

• Marketing Category: NDA
• Application Number: NDA019909
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-02-07
• Marketing End Date: 2019-08-31

Drug Details

Active Ingredients

Ingredient	Strength
ACYCLOVIR	200 mg/5mL

OpenFDA Data

• SPL SET ID: 6fe0ab86-9d81-461e-9c84-6ba724a91318
• Manufacturer:
  • Prestium Pharma, Inc.
• UNII:
  • X4HES1O11F
• RxNorm Concept Unique ID - RxCUI:
  • 307730
  • 197311
  • 213694
  • 197313
  • 197310
  • 201905
  • 201903
  • 213706
• UPC Code:
  • 0340076991551
  • 0340076953962
  • 0340076945554
  • 0340076949552

Pharmacological Class

• DNA Polymerase Inhibitors [MoA]
• Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]
• Nucleoside Analog [EXT]

NDC Crossover Matching brand name "ZOVIRAX" or generic name "Acyclovir"

NDC	Brand Name	Generic Name
0187-0993	Zovirax	acyclovir
0187-0994	Zovirax	acyclovir
0378-9735	Zovirax	Acyclovir
40076-949	ZOVIRAX	ZOVIRAX
40076-991	ZOVIRAX	ZOVIRAX
40076-953	ZOVIRAX	ZOVIRAX
40076-945	ZOVIRAX	ZOVIRAX
42254-149	ZOVIRAX	ZOVIRAX
0093-3630	Acyclovir	acyclovir
0093-8940	Acyclovir	Acyclovir
0093-8943	Acyclovir	Acyclovir
0093-8947	Acyclovir	Acyclovir
0143-9657	Acyclovir	Acyclovir
0143-9658	Acyclovir	Acyclovir
0168-0825	acyclovir	acyclovir
0378-8700	Acyclovir	acyclovir
0378-8712	Acyclovir	Acyclovir
0440-6030	Acyclovir	Acyclovir
0440-7033	acyclovir	acyclovir
0472-0082	Acyclovir	Acyclovir
0591-1159	Acyclovir	acyclovir
0713-0630	Acyclovir	Acyclovir
0904-5789	ACYCLOVIR	ACYCLOVIR
0904-5790	acyclovir	acyclovir
10544-039	Acyclovir	acyclovir
10544-089	Acyclovir	acyclovir
10544-101	Acyclovir	Acyclovir